On September 12, 2024 FibroBiologics, a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported the filing of a patent application with the United States Patent Office covering the use of fibroblast cell-based technology in generating three-dimensional hemopoietic organoids that can give rise to immune cells (Press release, FibroBiologics, SEP 12, 2024, View Source [SID1234656333]).

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The patent details methods of generating three-dimensional organoids capable of giving rise to hematopoietic cells, including precursors, and/or immune cells. This includes cells such as T cells, B cells, NK cells, macrophages, monocytes, neutrophils, platelets, red blood cells, myeloid-derived suppressor cells, mast cells, eosinophils, basophils, dendritic cells, and CAR-T cells.

"This method potentially offers a rapid, cost-effective, and scalable way to produce therapeutic hemopoietic organoids, which can be transplanted into a living organism to generate desired functional immune cells," commented Chief Scientific Officer of FibroBiologics, Hamid Khoja, Ph.D. "Additionally, the three-dimensional organoids can be ready for immediate transplantation into a subject within three days of culture or cryopreserved for later use."

"Our ongoing exploration of therapeutic applications using fibroblast cells continues to provide unique opportunities for our platform," commented Founder & CEO of FibroBiologics, Pete O’Heeron. "This patent, if issued, will allow us to pursue the development of a versatile, scalable solution for generating immune cells in vivo that could revolutionize regenerative medicine and cancer immunotherapy."

On September 12, 2024 Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to ITM), reported that it has entered into a multi-target antibody discovery collaboration with Umoja Biopharma, a transformative immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of CAR-T cell therapies in oncology and autoimmunity (Press release, Nona Biosciences, SEP 12, 2024, View Source [SID1234646541]). This collaboration leverages Nona’s proprietary fully human heavy chain only antibody (HCAb) technology to produce novel in vivo generated CAR-T cell therapy drug candidates.

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Fully human HCAbs have the potential to significantly reduce immunogenicity and offer versatility in CAR design due to their compact size, simplified structure, and precisely calibrated binding properties. This partnership aims to combine Nona’s HCAb Harbour Mice platform and direct CAR-function-based HCAb library screening platform (NonaCarFx) with Umoja’s VivoVec platform to develop novel in vivo CAR-T cell therapies and expand the potential reach of this innovative delivery technology.

Dr. Jingsong Wang, MD, PhD, Chairman of Nona Biosciences, commented, "We are excited to collaborate with Umoja Biopharma, a pioneer in cell and gene therapy. We believe that our HCAb Harbour Mice technology and NonaCarFxTM platform, alongside with our extensive experience in oncology and immunology, will empower Umoja to generate novel CAR-T cell therapies that benefit patients worldwide."

Byoung Ryu, PhD, Umoja’s Executive Vice President of Discovery Research and Vector Biology added, "Nona is a great partner for Umoja as we continue to move the CAR-T cell field towards directly administrated in vivo CAR therapeutics. Nona has demonstrated capabilities for generating highly functional CAR candidates, and we look forward to developing multiple in vivo drug candidates through this partnership and ultimately, helping change outcomes for these patients."

On September 12, 2024 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," reported the presentation of initial clinical data for HST-1011, an investigational oral, selective inhibitor of Casitas B-lineage lymphoma proto-oncogene (CBL-B) (Press release, HotSpot Therapeutics, SEP 12, 2024, View Source [SID1234646542]). Data from the Phase 1 monotherapy dose escalation portion of the study are being shared in a proffered oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024.

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"These initial data provide the first comprehensive insight into the clinical experience with a CBL-B inhibitor, a novel immuno-oncology mechanism with the potential to meaningfully transform the treatment paradigm for patients with solid tumors," said Timothy Reilly, Ph.D., Chief Development Officer of HotSpot. "Critically, HST-1011 demonstrated important linkages between drug exposures, target engagement, and proximal and distal measures of pharmacology, and we observed initial signs of clinical benefit, in a heavily pre-treated, advanced solid tumor patient population. We believe these data provide a strong foundation for the continued evaluation of HST-1011 in dedicated patient populations and for the further assessment of HST-1011 in combination with a PD-1 inhibitor, cemiplimab."

The Phase 1/2 study of HST-1011 (NCT05662397) is an open-label clinical study designed to evaluate HST-1011 alone and subsequently in combination with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), in adult patients with advanced solid tumors that are relapsed on or are refractory to anti-PD(L)-1 or standard of care therapies. The results being presented at ESMO (Free ESMO Whitepaper) include data from 28 patients in the monotherapy dose escalation portion of the study. The presentation describes the following data:

Patients had a diverse range of solid tumor types and were heavily pre-treated, with a median of four prior lines of therapy, including 89% who had been treated previously with immunotherapy.
HST-1011 was generally well tolerated across a range of twice-weekly doses, with no dose-limiting toxicities. The most frequent adverse events were gastrointestinal in nature, which were generally mitigated by the adoption of a prophylactic pre-treatment regimen.
Encouraging linkages were observed between pharmacokinetics (PK), target engagement, pharmacodynamics (PD) and initial signals of clinical activity. Despite the heavily pre-treated, advanced cancer patient population, indications of clinical benefit, including tumor stasis or shrinkage, were observed in 10 of the 28 patients across a range of tumor types and dose levels.
These encouraging data provide support for the ongoing evaluation of HST-1011 (NCT05662397).

Presentation details are as follows:

Title: First-in-Human (FIH) Phase 1 Data of HST-1011, an Oral CBL-B Inhibitor, in Patients with Advanced Solid Tumors
Speaker: Rachel E. Sanborn, M.D., Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR
Session Name: Proffered Paper session: Investigational immunotherapy
Session Date and Time: Fri., Sep. 13, 2024, 16:00-17:30 CEST
Presentation Time: 16:50-17:00 CEST
Location: Burgos Auditorium – Hall 5, Fira Barcelona Gran Via
Presentation Number: 991O

On September 11, 2024 Champions Oncology, Inc. (Nasdaq: CSBR), a global preclinical and clinical research services provider that offers end-to-end oncology solutions, reported its financial results for its first quarter of fiscal 2025, ended July 31, 2024 (Press release, Champions Oncology, SEP 11, 2024, View Source [SID1234646509]).

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First Quarter Highlights:

•Total revenue increased 12% to $14.1 million
•Margin improved to 50%
•Adjusted EBITDA of $2.0 million
•Net income of $1.3 million

Ronnie Morris, CEO of Champions, commented, "As outlined on our year-end earnings call, we’re cautiously optimistic that we’ve weathered the worst of the business downturn and we’re poised to emerge leaner and stronger. Our first quarter’s performance provided further evidence that we’re on a strategic course to more consistently deliver the results we have been striving to achieve." Morris added, "Our comprehensive platform, unique data, and strong team are the key ingredients for future growth that will drive long-term returns for our shareholders."

David Miller, CFO of Champions, added, "The first quarter saw a return to profitability as revenue increased 12% to $14.1 million while we reduced total costs by more than $2.0 million. The revenue increase, combined with mostly unchanged cost of oncology services, lifted our margin to 50%." Miller added, "While there will be some revenue and margin volatility over the coming quarters, our cost reductions should enable us to remain profitable on an adjusted EBITDA basis."

Exhibit 99.1
First Fiscal Quarter Financial Results

Total revenue for the first quarter of fiscal 2025 was $14.1 million compared to $12.6 million for the same period last year, an increase of 12%. Operational improvements and efficiencies implemented in the prior year led to an increase in our bookings to revenue conversion percentage contributing to the revenue growth. Total costs and operating expenses for the first quarter of fiscal 2025 were $12.7 million compared to $15.1 million for the first quarter of fiscal 2024, a decrease of $2.4 million or 15.8%.

For the first quarter of fiscal 2025, Champions reported income from operations of $1.3 million, including $258,000 in stock-based compensation and $449,000 in depreciation and amortization expenses, compared to a loss from operations of $2.6 million, inclusive of $423,000 in stock-based compensation and $445,000 in depreciation and amortization expenses, in the first quarter of fiscal 2024. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA income of $2.0 million for the first quarter of fiscal 2025 compared to an adjusted EBITDA loss of $1.7 million in the first quarter of fiscal 2024.

Cost of oncology services was $7.1 million for the three-months ended July 31, 2024, a decrease of $612,000, or 8.0% compared to $7.7 million for the three-months ended July 31, 2023. The decrease in cost of oncology services was primarily from a decline in outsourced lab services. For the three-months ended July 31, 2024, total margin was 49.7% compared to 38.8% for the three-months ended July 31, 2023. The improved margin resulted primarily from a combination of an increase in revenue on a lower cost base due to operational efficiencies implemented and other cost reduction initiatives.

Research and development expense for the three-months ended July 31, 2024 was $1.5 million, a decrease of $1.3 million or 47.9%, compared to $2.8 million for the three-months ended July 31, 2023. The decrease was primarily due to reduced investment in research and development, including our target discovery program. Sales and marketing expense for the three-months ended July 31, 2024 was $1.7 million, a slight decrease of $17,000, or 1.0%, compared to $1.7 million for the three-months ended July 31, 2023. General and administrative expense for the three-months ended July 31, 2024 was $2.5 million, a decrease of $413,000, or 14.0%, compared to $2.9 million for the three-months ended July 31, 2023. The decrease was primarily from a reduction in compensation and recruitment expenses.

Net cash provided by operating activities was approximately $311,000 for the three-months ended July 31, 2024 and was primarily due to our operational income, offset by net changes in our working capital accounts in the ordinary course of business. There were no investing activities for the first quarter of fiscal 2025. Net cash used in financing activities for the three-months ended July 31, 2024 was approximately $37,000 resulting from financing lease payments.

The Company ended the quarter with cash on hand of approximately $2.9 million. The Company has no debt.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its first quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 726315, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by or before September 16, 2024 in the Company’s Form 10-Q at www.championsoncology.com.

On September 11, 2024 Ichnos Glenmark Innovation (IGI), an alliance between Ichnos Sciences Inc., a global fully-integrated clinical-stage biotech company developing multispecifics in oncology, and Glenmark Pharmaceuticals Ltd., reported that Nature Cancer published a research article describing the preclinical development of ISB 2001, a first-in-class trispecific antibody targeting BCMA and CD38 on myeloma cells and CD3 on T cells (Press release, Ichnos Sciences, SEP 11, 2024, View Source;utm_medium=rss&utm_campaign=igi-announces-publication-in-nature-cancer-on-isb-2001-igis-innovative-trispecific-antibody-for-relapsed-refractory-multiple-myeloma [SID1234646510]). ISB 2001 is currently being investigated in a Phase 1 clinical study in relapsed/refractory multiple myeloma (r/r MM).

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"Despite advances with monoclonal antibodies and earlier-generation bispecifics, a high relapse rate and resistance to currently available therapeutics are persistent challenges in treating multiple myeloma," said Cyril Konto, M.D., President, Executive Director and CEO of IGI. "The publication of ISB 2001 preclinical data in Nature Cancer supports the differentiation and mechanism of action of IGI’s multispecific antibody. These comprehensive findings underscore the therapeutic potential of ISB 2001, now in Phase 1 clinical testing, and we look forward to sharing our continued progress."

Key findings of the Nature Cancer article, "ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells" include the following

The data demonstrate that ISB 2001 can overcome resistance mechanisms by dual tumor targeting via binding and cytotoxicity of tumor cells with low expression of CD38 or BCMA.
ISB 2001’s architecture is optimized to support robust killing of tumor cells while limiting CD38 on-target, off-tumor activity.
ISB 2001 demonstrated increased killing of tumor cells compared to BCMA-targeted T cell engagers in vitro, in vivo and ex vivo; induced complete tumor regression in humanized mouse models; and demonstrated superior potency compared to standard combination of therapies.
"We leveraged our proprietary BEAT platform to create a highly specific antibody that increases binding to MM cells while minimizing off-target activity," said Mario Perro, Ph.D., Head of Biologics Research at IGI. "These preclinical data demonstrate the potential of a trispecific approach to augment immune cell activation and achieve more precise tumor targeting and killing."
The paper can be found at View Source

ISB 2001 – Mechanism of Action
ISB 2001 is the first T cell-engaging antibody that simultaneously targets BCMA and CD38 on MM cells. It is a trispecific antibody based on BEAT (Bispecific Engagement by Antibodies based on the TCR) technology, a proprietary platform allowing maximal flexibility and manufacturability of full-length multispecific antibodies. ISB 2001 combines three proprietary antigen-binding arms, each targeting a different antigen, with one arm binding to the epsilon chain of CD3 on T cells, and the other two binding BCMA and CD38 on MM cells. Its fragment crystallizable (Fc) domain was fully silenced to suppress Fc effector functions. ISB 2001 redirects CD3+ T lymphocytes to kill tumor cells expressing BCMA and CD38. Targeting of two different tumor-associated antigens instead of one allows for avidity binding to MM cells expressing very low levels of BCMA and CD38.